LTAP Block in Endometriosis Surgery - a Randomised Controlled Double-blind Trial

Oulu University Hospital46 enrolled

Overview

The purpose of this study is to compare the efficacy and safety of laparoscopically inserted transversus abdominis plane block (LTAP) in comparison to local wound analgesia in laparoscopic surgery due to suspected or diagnosed peritoneal endometriosis.

The LTAP-trial is a prospective randomized controlled double-blinded study comparing the efficacy and safety of LTAP with local wound analgesia in laparoscopic endometriosis surgery. Patients are randomized to receive LTAP with levobupivacain and wound infiltration with placebo or wound infiltration with levobupivacain and LTAP with placebo. The primary outcome is postoperative opioid consumption measured by Patient Controlled Analgesia -pump (PCA). Secondly, subjective postoperative pain up to 24 h postoperatively will be measured by Numeric Rating Scale (NRS). Additional outcome measures are factors related to recovery and length of stay in the hospital as well as a 6 month follow-up survey regarding pain and general wellbeing after surgery. A total of 46 patients will be randomized in a proportion of 1:1.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Endometriosis; Peritoneum Postoperative Pain

Interventions

Postoperative pain management: LTAP block or local wound anesthesia with levobupivacainePROCEDURE

Postoperative pain management

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Surgery indicated because of pain caused by diagnosed or suspected peritoneal endometriosis * ASA class 1-3 * Patient is capable of giving informed consent Exclusion Criteria: * Obstructive sleep apnea * ASA class \>4 * Other significant risks associated with opioid use * Contraindications for local anesthetics or NSAIDs * Regular opioid consumption before operation

Locations (1)

Oulu mUniversity Hospital

Oulu, Finland

Outcomes

Primary Outcomes

Postoperative opioid consumption

Oxicodone consumption measured via PCA-pump in Morphine equivalents

Time frame: 24 hours

Secondary Outcomes

Postoperative pain assessed by NRS (numeric rating scale)

NRS (numeric rating scale) with 0 (minimum) meaning no pain and 10 (maximum) meaning the worst imaginable pain

Time frame: Recovery room immediately postoperatively; on ward 6, 12 and 24 hours postoperatively

Pain at six months postoperatively; assessed by NRS (numeric rating scale), (questionnaires sent to the patients)

NRS (numeric rating scale) with 0 (minimum) meaning no pain and 10 (maximum) meaning the worst imaginable pain

Time frame: 6 months postop

Quality of life at six months postoperatively; assessed by EHP-30 (endometriosis-related health profile) (questionnaires sent to the patients)

EHP-30 (endometriosis health profile) with 0% meaning no effect on quality of life and 100% meaning maximum worsening effect on quality of life

Time frame: 6 months postop

Intra- or postoperative complications

Blood loss (millilitres for each participant), Reoperation (number of participants; yes/no), Hospital stay (hours/days for each participant), Readmission (number of participants for each study group), complications according to Clavien Dindo classification (Grade I meaning any deviation from the normal postoperative course; up to grade V meaning death of patient)

Time frame: Up to 6 months postop

Data from ClinicalTrials.gov

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